For personal use only Investor Presentation July 23, 2013 Disclaimer [PDF]

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Investor Presentation July 23, 2013

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Investor Presentation April 3, 2013 Investor Presentation July 23, 2013

Disclaimer

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Certain statements made in this presentation are forward looking statements within the meaning of the safe harbour provisions of the United States Private Securities Litigation Reform Act of 1995. These forward looking statements are not historical facts but rather are based on Viralytics’ current expectations, estimates, assumptions and projections about the industry in which Viralytics operates. Material referred to in this document that use the words ‘estimate’, ‘project’, ‘intend’, ‘expect’, ‘plan’, ‘believe’, ‘guidance’ and similar expressions are intended to identify forward looking statements and should be considered an at-risk statement. These forward looking statements are not a guarantee of future performance and involve known and unknown risks and uncertainties, some of which are beyond the control of Viralytics or which are difficult to predict, which could cause the actual results, performance or achievements of Viralytics to be materially different from those which may be expressed or implied by these statements. These statements are based on our management’s current expectations and are subject to a number of uncertainties and risks that could change the results described in the forward-looking statements. Risks and uncertainties include, but are not limited to, general industry conditions and competition, general economic factors, the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally, and challenges inherent in new product

development. Investors should be aware that there are no assurances that results will not differ from those projected

and Viralytics cautions shareholders and prospective shareholders not to place undue reliance on these forward-looking statements, which reflect the view of Viralytics only as of the date of this presentation. Viralytics is not under a duty to update any forward-looking statement as a result of new information, future events or otherwise, except as required by law or by any appropriate regulatory authority.’

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Viralytics Ltd (ASX:VLA) is an Australian ASX listed biotechnology company focussed on developing targeted oncolytic virotherapy to treat a range of cancers

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Investor Presentation April 3, 2013 Investor Presentation July 23, 2013

Investment Highlights

Lead product is CAVATAK™ with broad anti-cancer activity
CAVATAK™ ¡advancing in Phase 2 clinical trial in the US

– 38 of target 54 evaluable melanoma patients recruited to date – Strong interim results with solid progress towards achieving the primary endpoint – Activity in both injected and metastatic (secondary) tumours – Well tolerated with no drug related serious adverse events – Full recruitment may occur by end 2013

Planned Phase 1/2 intravenous trial in the UK in 2013 in solid cancers
Potential for synergy when used with other anti-cancer agents
Achieved GMP manufacture
Robust intellectual property/patent portfolio
Big Pharma interest in field with 2011 US$1.0 billion Amgen/Biovex deal

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Investor Presentation April 3, 2013 Investor Presentation July 23, 2013

Corporate Snapshot

Ticker Symbol:

VLA

Share Price:

A$0.31

Outstanding Shares:

87.2m

Outstanding Options:

5.9m

Market Cap:

A$27m

Debt/Convertibles:

NIL

Trading Range:

A$0.20 – 0.465 (last 12 months)

Top 20 Shareholders Own:

~15%

Cash:

A$5.1m (as at June 30, 2013)

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CAVATAK™

Proprietary formulation of the genetically unmodified human Coxsackievirus

A21 (involved in common cold)

Binds to ICAM-1 receptor present in abundance on the surface of many

cancer cell types

Acts to kill local and metastatic cancer cells by direct oncolytic and potential

immunotherapeutic activity

Targeted towards cancer cells and well tolerated in 66 patients to date
Potential intravenous as well as intratumoural use
Possible application across a range of common cancer types including

prostate, lung, melanoma and bladder cancer

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Cancer Type Rank *Estimated New Cases in the US in 2013 Prostate #1 238,590 Lung #3 228,190 Melanoma #5 76,690 Bladder #6 72,570

*USA National Cancer Institute, 2013

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Melanoma

A malignant skin tumour that can grow and spread to lymph nodes and

internal organs, potentially resulting in death

World Health Organization reports the incidence of malignant melanoma is

increasing faster than any other cancer

Datamonitor Report 2012*
Approximately 125,700 men and women were diagnosed with malignant

melanoma in the big 7 markets (US, Japan, France, Germany, Italy, Spain, and the UK) in 2011

Branded melanoma product sales to experience a dramatic increase from

$1.1Bn to $2.4Bn in big 7 markets from 2012 – 2021

Drug resistance and toxicity still major problems thus there are opportunities for

developers to move into the market

7 *Datamonitor Healthcare - Market and Product Forecasts Melanoma October 2012

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CAVATAK™ ¡– Preclinical Results

8 CAVATAKTM

Potent and relatively rapid cancer killing activity across a wide range of

human cancers

Synergistic activity observed when used in combination with chemotherapy
r radiation therapy
Significant reduction or elimination of human cancers including melanoma in

mice after virus injection

Mice dosed with 108 TCID50 CAVATAKTM intratumourally and

then assessed 45 days later.

Melanoma presence shown by colour scale

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CAVATAK™ ¡– Phase 1 Results

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Five Australian studies – 28 patients
Intratumoural and intravenous dosing
CAVATAK™ well tolerated
Evidence of tumour stabilisation in some patients

Name Type Disease Stage Indication

No. of

Patients VLA-01 Single Dose Intratumoural Stage IV Melanoma 2 VLA-02 Single Dose Intratumoural Stage IV Melanoma 3 VLA-03 Multi-dose Escalation Intratumoural Stage IV Melanoma 9 VLA-04 Single Dose Intravenous Stage IV Melanoma, Colorectal, Breast, Prostate 10 VLA-06 Multi-dose Intratumoural Stage IV Head and Neck 4 Total 28

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CAVATAK™ – Phase 2 CALM Study

Presentation by Dr Robert Andtbacka (World Congress of Melanoma, July 18, 2013)

19 Courtesy Dr R Andtbacka, Lead Study Investigator, Huntsman Cancer Institute

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Phase 1/2 study in approximately 30 late stage patients with melanoma, prostate,

lung or metastatic bladder cancer

Plan to commence in 2013 in 3 prestigious UK cancer centres
Will investigate multiple intravenous (IV) dosing of CAVATAK™ with and without

standard chemotherapy (e.g. docetaxel)

In vitro studies demonstrate potential benefits from a combination of CAVATAK™ ¡

and docetaxel

Significant market expansion opportunity if safe and effective by IV administration

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CAVATAK™ - Phase 1/2 STORM Study

(Systemic Treatment of Resistant Malignancies)

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Investor Presentation April 3, 2013 Investor Presentation July 23, 2013

Superficial Bladder Cancer

Sixth most common cancer in US
Estimated global prevalence of 2.7 million patients
Results in significant mortality, with overall 5-year survival rates of only 57% and

47% for men and women, respectively, when muscle-invasive disease

Significant economic burden with estimated cost of $200,000 per patient
No treatment in the last decade has made significant improvements in patient

survival

BCG may control disease temporarily but is associated with significant toxicity

and patient morbidity.

Unmet need for non-toxic effective agents particularly in older patients

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CAVATAK™- Preclinical studies in Bladder Cancer

Viralytics collaboration with Professor Pandha from University of Surrey
Evaluated the activity of CAVATAK™ in superficial bladder cancer
Assessed CAVATAK™ in combination with either radiation or chemotherapy
Both combinations synergistically increase the anti-cancer activity in bladder

cancer cell lines

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10 20 30 40 50 60 70 80 90 100

18.3/0.82 9.1/0.42 4.6/0.21 2.298/0.105 1.149/0.052

% cancer cell survival CVA21 Mitomycin C COMB Combination

f CVA21 and

Mitomycin C

Courtesy Prof Pandha The Seventh International Meeting on Replicating Oncolytic ¡Virus ¡Therapeutics” ¡in ¡Quebec, ¡Canada. ¡

The effect of the combination of CVA21 and Mitomycin C on T24 cancer cells “The ¡significantly increased oncolytic activity of CAVATAK™ ¡in ¡bladder ¡cancer ¡cell ¡cultures ¡when ¡used ¡in ¡ combination with chemotherapy or radiation therapy represents a potentially compelling new treatment regimen. There is urgent need for improved therapies for bladder cancer ¡and ¡the ¡combination ¡of ¡CAVATAK™ ¡and ¡chemo ¡or ¡ radiation ¡therapy ¡appears ¡very ¡promising,” ¡ Professor Hardev Pandha, Department of Oncology, The University of Surrey, UK

Dose: MOI/ ug per ml

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Manufacture

cGMP formulation produced at Sigma-Aldrich in the US
Purified following growth in mammalian cell culture
Highly stable at -70 °C storage
Simple manufacturing process
Low manufacturing costs

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Strong Intellectual Property Position

8 Patent Families 25 Patents granted worldwide and 22 pending Minimal Royalties No Infringements or Disputes

+ + +

Date Patent Family Applications 2013 Major ¡synergy ¡between ¡Coxsackievirus ¡A21 ¡(CAVATAK™) ¡and ¡radiation ¡therapy ¡or ¡chemotherapy ¡in ¡bladder ¡ cancer 2012 Genetically stable oncolytic virus 2012 Pharmaceutical composition 2006 Method and Composition in the treatment of Neoplasms 2006 Methods and Compositions for the treatment of Hematologic Cancers 2005 Modified Oncolytic Viruses 2004 A method of treating malignancy in a subject via direct picornaviral-mediated oncolysis 2001 A method of treating a malignancy in a subject and a pharmaceutical composition for use in same Orphan status in the USA: 7 years market exclusivity BLA approval in the USA: 12 years data exclusivity

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CAVATAK™ Development/ Business Strategy

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Phase 1 trials Intratumoural and Intravenous Double Blind Placebo Controlled Trial in Melanoma patients Phase 2 CALM intratumoural trial in melanoma patients License to Big Pharma Completed Underway Future Phase 1/2 STORM intravenous trial in solid tumour patients

2012

CAVATAKTM / chemotherapy in preferred solid tumour type Planned Q3/4 2013

? ? ?

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Amgen-Biovex

Biovex was a private US based biotech
Investigational product (OncoVEXGM CSF) contains a modified herpes virus

administered intratumourally

Completed a single, small, open-label Phase 2 study in 50 patients (Overall

Response Rate of 26%)

Initiated a 420 patient Phase 3 melanoma trial after $70M capital raising
Amgen acquired Biovex in 2011 and paid US$425 million cash upfront with a

potential further US$575 million milestone payments

Primary endpoint met in Phase 3 melanoma trial with a Durable Response

Rate of 16%

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Viralytics’ ¡Value ¡Growth ¡Potential

Compelling comparative value based on progress in Phase II trial

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2 other significant companies: Oncolytics Biotech & Jennerex

200 400 600 800 1000 1200 Amgen/Biovex Oncolytics Biotech Jennerex Viralytics US$1B US$230m US$116m (European rights only) US$25m

Company Commercial Value/ Deals Stage of Development Oncolytics Biotech (Canada) US ~$230 million Market Capitalisation Phase III: Head & Neck cancer Jennerex (USA) US ~$116 million European rights licensing development deal 2010 Phase II: Liver cancer Phase I: Intravenous study

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Investor Presentation April 3, 2013 Investor Presentation July 23, 2013

Summary

Lead product is CAVATAK™ with broad anti-cancer activity
CAVATAK™ advancing in Phase 2 clinical trial in the US in melanoma patients

– Strong interim results with solid progress towards achieving the primary endpoint – Activity in both injected and metastatic (secondary) tumours – Well tolerated with no drug related serious adverse events – Full recruitment may occur by end 2013

Further clinical milestones in near term
Significant opportunity in rapidly growing melanoma market
Planned Phase 1/2 intravenous trial in the UK in 2013 in solid cancers
Promising outcomes in preclinical studies in bladder cancer
Potential use as monotherapy or in combination with other agents
Compelling comparative value based on progress in Phase II trial

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CAVATAK™

Dr. Malcolm McColl

Chief Executive Officer Email: malcolm.mccoll@viralytics.com Web: www.viralytics.com

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Leadership Team - Experience and Track Record

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Executive Dr Malcolm McColl | Chief Executive Officer – More than 20 years experience in the pharmaceutical and biotechnology sector including senior executive roles with major corporations in North America, Europe and Asia

Pacific. Significant partnering and transactional experience particularly in the oncology sector.

Associate Professor Darren Shafren | Chief Scientific Officer and Inventor of Technology – More than 25 years in Virology research focusing on oncolytic viruses and cancer cell interactions. The results of his research have been published in various internationally respected scientific journals, including Clinical Cancer Research and The Journal of Virology. Board Mr Paul Hopper | Chairman – International and ASX biotech capital markets experience. Head of Life Sciences and Australia Desks at Los Angeles-based investment bank, Cappello Capital Corp. Dr Phillip Altman | Authority on clinical trials and regulatory affairs and Founder of Pharmaco, one of the first CROs in Australia. Mr Peter Molloy | Previously CEO of three biotech companies; Managing Director and Vice President of Strategic Marketing at Pharmacia. Dr Leonard Post | Former director of BioVex and Senior Vice President of R&D at Onyx Pharmaceuticals. Extensive oncolytic virotherapy and oncology experience. US based.